Medigene AG Medigene reports financial & business results for the first six months of 2019

Medigene AG  , a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported on their business performance and financial results for the first half of 2019. In the first six months of 2019, the Company made additional advances in their immunotherapy programs and reported a significant revenue increase, primarily due to the partnerships with bluebird bio and Roivant/Cytovant. Medigene confirms the financial guidance for the fiscal year 2019.

“In the first half of 2019, we reported on clinical progress for three TCR therapy projects. Importantly, we initiated patient treatment in our ongoing study with Medigene’s first TCR therapy, MDG1011. We also commenced preparations for the Phase I trial of our second TCR therapy, MDG1021, with Leiden University Medical Center, scheduled to start in 2020. Additionally, our partner bluebird bio announced its intention to start a Phase I clinical trial in 2020 with the first TCR from our partnership. Also, Medigene was able to present promising clinical interim results from our DC vaccine trial,” said Prof. Dolores Schendel, CEO/CSO of Medigene AG. “In addition, we established an important strategic partnership with Roivant/Cytovant for cellular therapies in Asia which will enable us to bring much needed treatment alternatives to this patient population. We are very pleased with the progress we have made this year and look forward to making further advancements with our proprietary immunotherapy programs as well as with those of our partners in the coming months.”

• Major events since the beginning of 2019:
  In June, Medigene presented an interim analysis from its ongoing Phase I/II clinical trial with dendritic cell (DC) vaccines in acute myeloid leukemia (AML) patients at the congress of the European Hematology Association (EHA). The completion of the ongoing trial is scheduled for the end of 2019, following a two-year treatment period.
• In May, Medigene entered into a clinical trial agreement for its second T cell receptor (TCR) immunotherapy MDG1021 with Leiden University Medical Center. The Phase I clinical trial using an HA-1-specific TCR is scheduled to start in 2020 as Medigene’s second company-sponsored clinical TCR-T trial.
•  In May, Medigene’s partner bluebird bio presented preclinical data for the first TCR candidate from the Medigene collaboration. The data demonstrated a high antigen sensitivity of the MAGE-A4-TCR, with strong recognition of tumor cell lines and durable tumor elimination in a subcutaneous in vivo melanoma model. Additionally, the data showed functional responses in both CD8+ and CD4+ T cell populations, demonstrating that addition of the CD8 co-receptor will not be needed for use of this MAGE-A4-TCR in solid tumors. bluebird bio intends to commence clinical development of the TCR targeting the MAGE-A4 tumor antigen in 2020; bluebird bio may potentially combine this highly active TCR with other technologies to enhance T cell function in solid tumor microenvironments in next generation programs.
•  In April, Medigene entered into a license and cooperation agreement with the Roivant group on behalf of the newly founded Cytovant Sciences for research and discovery of cell therapies in Asia. Medigene granted Cytovant exclusive licenses to develop, manufacture, and commercialize Medigene’s TCR-based immunotherapy targeting the NY-ESO-1 antigen as well as a DC vaccine targeting WT-1 and PRAME. In addition, Roivant/Cytovant and Medigene entered into a strategic collaboration and discovery agreement for TCR immunotherapies for two additional targets. Medigene will be responsible for the generation and delivery of the TCR constructs and Cytovant will ultimately assume sole responsibility for the development and commercialization of these TCR therapies; the TCRs will be tailored specifically for Asian patients. Under the terms of the transaction, Medigene received an upfront payment of USD10 million and is eligible to receive development, regulatory, and commercial milestone payments, which in aggregate could total over USD1 billion for the four products across multiple indications.
•  In April, Medigene sold the remaining rights and stock of Veregen® to Aresus Pharma and thereby completed its transformation into a pure-play immunotherapy company.
•  In February, Medigene dosed the first patient in the Phase I/II clinical trial of Medigene’s first T cell immunotherapy (TCR-T) MDG1011 to treat acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma.
•  In January, Medigene licensed a co-stimulatory receptor from Helmholtz Zentrum Munich to enhance TCR therapies for solid tumors.
• Key figures in the first half of 2019:
  Revenue from the core immunotherapies business grew by 47% to Eur4,926k (6M-2018: Eur3,358 k) due to the partnership with bluebird bio and a new partnership with Roivant/Cytovant.
•  Total revenue increased by 33% to Eur5,640k (6M-2018: Eur4,253k).
•  Research and development expenses increased as planned by 26% to Eur10,922k (6M-2018: Eur8,669 k) due to an extension of the preclinical and, in particular, the clinical development and manufacturing activities for Medigene’s immunotherapy programs.
•  EBITDA loss increased by 77% to Eur13,208 k (6M-2018: Eur7,479k); the increase of EBITDA loss was 14% (Eur8,532 k) when excluding the Veregen® effect in the non-core business.
•  Cash and cash equivalents and time deposits were Eur65,256 k as at June 30, 2019 (December 31, 2018: Eur71,408 k).

Financial guidance 2019:

• Medigene confirmed the financial guidance issued in the 3M-2019 quarterly report:
  The Company anticipates generating total revenue of Eur10 – 11m in 2019.
• Due to anticipated advances in development projects, Medigene is projecting research and development expenses of Eur24 – 29m and forecasts an EBITDA loss of Eur23 – 28m.
•  This assessment does not include potential future milestone payments or cash flows from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene.
•  Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the planning horizon of two years.

Immunotherapy Outlook:
Current Phase I/II clinical trial with Medigene’s first TCR therapy MDG1011
Medigene commenced the Phase I/II clinical trial of its TCR-based T cell therapy MDG1011 and began treating patients in the first quarter of 2019. There are currently six active study centers and Medigene anticipates opening additional sites as previously guided. In 2019, the focus of the trial will be patient recruitment in the first dosing cohorts to assess the safety and tolerability of the treatment with MDG1011.

Planned Phase I/II clinical trial with Medigene’s second TCR therapy MDG1021
Based on the Clinical Trial Agreement entered into with the Leiden University Medical Center (LUMC) in May 2019, Medigene plans to conduct a Phase I clinical trial with Medigene’s TCR therapy MDG1021, targeting the HA-1 antigen. Medigene will assess the safety, feasibility and preliminary efficacy of MDG1021 in patients with relapsed or persistent hematologic malignancies following allogeneic hematological stem cell transplantation. The study is scheduled to start in 2020 as Medigene’s second company-sponsored clinical TCR-T trial after preparation for the trial is completed.

Development of additional TCR candidates
Now that a robust platform for the discovery and characterization of new TCR candidates has been fully established, building a solid pipeline of potential TCR-development candidates is an important goal to secure future clinical programs for both internal and existing or future partners.

In 2019, in addition to the MDG1011 clinical trial, Medigene will therefore work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.

Optimization of future TCR therapies for solid tumors
The chimeric co-stimulator receptor (PD-1/4-1BB molecule) licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.

TCR partnerships
In addition, Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery. bluebird bio announced to commence clinical development in solid tumors with the first TCR from this partnership (a TCR targeting MAGE-A4) in 2020.

Within the framework of the partnership entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake the preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform.

Dendritic cell vaccines (DCs)
Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The final data will be available towards the end of 2019/beginning of 2020.

Medigene AG  is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene focuses on the development of personalized T cell-based therapies, with projects currently in preclinical and clinical development. For more information, please visit http://medigene.com